Job Title: Research Associate, Drug Product Analytical Development Job Summary
- The primary responsibilities of this contract role will be to support testing of analytical methods for messenger RNA therapeutic drug products. The incumbent will be expected to undertake laboratory work to support testing and data collation for internal stakeholders, including but not limited to Research, Drug Product Process Development, Formulation Development Groups, and Drug Product Process Sciences .
- Additional responsibilities include troubleshooting analytical methods when required, trending analytical method performance, and support for drug product in-process non-GMP manufacturing. This position will support cross-functional teams in Research and Development, Production and Quality.
Education & Qualifications Minimum Qualifications
- Undertake analytical testing using established methods to generate high quality data to support internal departments.
- Support in process testing for internal drug product manufacturing.
- Troubleshoot analytical instrumentation and methods as required, and trend analytical method performance. Maintain good GLP lab and documentation practices.
- Provide summary presentations and detailed reports to internal and external stake holders.
- BS with relevant industry or undergraduate experience in analytical chemistry.
- BS/MS in Analytical Chemistry, Biochemistry, Chemical Engineering, or closely related field.
- Knowledge of HPLC and modes of separation (e.g. ion exchange, reverse phase ion pair, size exclusion).
- Knowledge of equipment platforms (e.g. Thermo, Waters, Agilent) and data processing software (e.g. Chromeleon, Chemstation, Empower).
- Knowledge of nucleic acid chemistry and biology and standard methods of analysis of these molecules.
- BS with 3 years of relevant industry experience.
- MS with 2 years of relevant industry experience.
- Proven track record for managing method transfers and qualifications at external CMOs/CRO's.
- Hands on industry experience with analytical development for RNA and DNA therapeutics
- Knowledge of GMP and GLP regulations and guidance on analytical method validation (ICH Q2 (R1)
- Effective team player
- Clear verbal and written communication skills
- Drive and initiative to deliver on goals in a fast-paced environment
- Efficiency in execution
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.